The present disclosure refers to a method for producing a sterilized subcutaneous access device and a sterilized subcutaneous access device.
Medical devices such as insulin pumps or devices for continuous measurement of an analyte in a bodily fluid, for example, blood glucose or lactate, are operated electrically, and therefore require a power or energy source. The devices may be for use by patients who are not confined to bed, so they must rely on batteries or secondary batteries. The preference is for primary elements, but rechargeable batteries are also usable. For example, document US 2008/0242962 A1 discloses the use of a round cell battery.
In document U.S. Pat. No. 6,561,978 B1 flexible printed batteries known as such for decades (see, for example, U.S. Pat. No. 3,230,115) are proposed for use in medical devices. A continuous sensor system using the iontophoresis principle as a method for obtaining samples is disclosed. The use of flexible printed battery is proposed.
Document US 2005/0159752 A1 discloses the use of sterile battery packs with chemistry based on lithium/manganese dioxide.
When standard commercial batteries or rechargeable batteries are used, a device must be adapted to the standardized geometries of available cells during its development, and suitable contacting solutions must be created that exert sufficient force on the cells to guarantee reliable contact. Consequently, the contacts, and the housing that supports them, must be made from materials that are stiff enough to ensure a prolonged shelf life. Both requirements are complex, and require installation space that is difficult to reconcile with miniaturization.
Document US 2002/040208 A1 discloses a system for delivering fluid to a patient, including a fluid delivery device having a dispenser for causing fluid from a reservoir to flow to an exit port assembly, a local processor connected to the dispenser and programmed to cause fluid flow to the exit port assembly based upon flow instructions, and a local communication element connected to the local processor. A remote control device is separate from the fluid delivery device and includes a remote processor, user interface components connected to the remote processor, and a remote communication element connected to the remote processor and adapted to communicate with the local communication element of the fluid delivery device such that information can be transferred between the local processor and the remote processor. The system also includes at least one data collection assembly adapted to at least one of measure, monitor, calculate, and store a physiologic parameter of a patient.
In document WO 2013/136181 A2 some embodiments have a pump assembly mounted to or supported by a dressing for reduced pressure wound therapy. The dressing can have visual pressure, saturation, and/or temperature sensors to provide a visual indication of the level of pressure, saturation, and/or temperature within the dressing. Additionally, the pump assembly can have a pressure sensor in communication with the flow pathway through the pump, and at least one switch or button supported by the housing, the at least one switch or button being accessible to a user and being in communication with the controller. The pump assembly can have a controller supported within or by the housing, the controller being configured to control an operation of the pump. The pump can be configured to be sterilized following the assembly of the pump such that all of the components of the pump have been sterilized.
In document EP 2 277 554 A1 a radiation sterilization method of a disposable medical device and a manufacturing method are provided, the method comprising the steps of packaging a disposable medical device, which has applied thereto a hydrophilic polymer coating, with a gas permeable packaging material, controlling a product moisture content of the thus packaged medical device by maintaining the device in a given humidity atmosphere for not less than a time at which an equilibrated moisture content is reached, and subjecting, to radiation sterilization, the medical device whose product moisture content has been controlled, so that an eluted matter is reduced in amount and a sliding performance is ensured according to the radiation sterilization method of the hydrophilic polymer-coated, disposable medical device and the manufacturing method.
Document WO 2011/015659 A1 discloses a base part for a medication delivery device. The base part is during use fastened to a patient's skin and connected to a cannula part which cannula part is positioned at least partly subcutaneous. The base part is also connected to a sensor unit which can detect one or more components, e.g., glucose content in the patient's blood. The base part comprises fastening means which fastening means releasably attach the reservoir/delivery part to the base part during use and a first fluid path or means corresponding to a first fluid path from a reservoir permitting a flow of fluid between the reservoir/delivery part and the base part when the reservoir/delivery part is attached to the base part, the first fluid path comprises means for interrupting the fluid flow when the detachable reservoir/delivery part is not attached to the base part and opening the fluid path when the delivery part is attached to the base part. The base part also comprises a lower mounting surface and one or more openings through which two or more subcutaneous units in the form of at least one cannula and at least one sensor part or at least two cannulas extend and it comprises a second fluid path permitting a flow of fluid from the outlet of the first fluid path to an inlet of a subcutaneously positioned cannula during use, and a signal path is provided from the reservoir/delivery part to a sensor contact part. The base part is characterized in that the second fluid path is in fluid connection with an end opening of a subcutaneously positioned cannula during use.
In document WO 2006/108809 A1 a medical device is provided comprising a transcutaneous device unit and a process unit. The transcutaneous device unit may comprise a transcutaneous device for transporting a fluid through a skin portion of a subject, and a mounting surface adapted for application to the skin of the subject. The process unit may comprise a reservoir adapted to contain a fluid drug, the reservoir comprising an outlet means allowing the transcutaneous device to be arranged in fluid communication with an interior of the reservoir, and an expelling assembly for expelling a fluid drug out of the reservoir and through the skin of the subject via the transcutaneous device. The transcutaneous device unit and the process unit further comprise coupling means allowing the reservoir unit to be secured to the transcutaneous device unit in the situation of use. By this arrangement a two-unit system is provided which can be used in a convenient and cost-effective manner.